Amoxicillin and clavulanic acid ratiopharm Italia: detailed information

Package leaflet: Information for the user

Amoxicillin and Clavulanic Acid ratiopharm Italia 875 mg/125 mg powder for oral suspension
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Amoxicillin and Clavulanic Acid ratiopharm Italia is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid ratiopharm Italia
How to take Amoxicillin and Clavulanic Acid ratiopharm Italia
Possible side effects
How to store Amoxicillin and Clavulanic Acid ratiopharm Italia
Contents of the pack and other information

1. What Amoxicillin and Clavulanic Acid ratiopharm Italia is and what it is used for

Amoxicillin and Clavulanic Acid ratiopharm Italia is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin is an antibiotic belonging to the group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive).
The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid ratiopharm Italia is used in adults and children to treat the following infections:

middle ear and sinus infections;
respiratory tract infections;
urinary tract infections;
skin and soft tissue infections, including dental infections;
bone and joint infections.

2. What you should know before taking Amoxicillin and Clavulanic Acid ratiopharm Italia

Do not take Amoxicillin and Clavulanic Acid ratiopharm Italia:

if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6);
if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck;
if you have previously had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Do not take Amoxicillin and Clavulanic Acid ratiopharm Italia if any of these cases apply to you.
If you have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ratiopharm Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ratiopharm Italia.
Speak with your doctor or pharmacist before taking this medicine if you:

have infectious mononucleosis (commonly known as “kissing disease”, characterized by fever and swollen glands (lymph nodes) in the neck);
have previously been treated for liver or kidney problems;
do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid ratiopharm Italia.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of amoxicillin and clavulanic acid or a different medicine.
Conditions you should monitor
Amoxicillin and Clavulanic Acid ratiopharm Italia may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking Amoxicillin and Clavulanic Acid ratiopharm Italia to reduce any risks. See “Conditions you should monitor” in section 4.
Blood and urine tests
If you are about to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid ratiopharm Italia. This is because Amoxicillin and Clavulanic Acid ratiopharm Italia may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid ratiopharm Italia
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid ratiopharm Italia, you are more likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillin and Clavulanic Acid ratiopharm Italia.
If you are taking medicines such as acenocoumarol or warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid ratiopharm Italia, additional blood tests may be necessary.
Amoxicillin and Clavulanic Acid ratiopharm Italia may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid ratiopharm Italia may affect the effectiveness of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid ratiopharm Italia may cause side effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid ratiopharm Italia contains approximately 2.6 g of sucrose (sugar) per sachet. This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Amoxicillin and Clavulanic Acid ratiopharm Italia

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
Amoxicillin and Clavulanic Acid ratiopharm Italia 875 mg/125 mg powder for oral suspension in sachets

The recommended dose is 1 sachet twice a day
The maximum dose is 1 sachet three times a day

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid ratiopharm Italia 875 mg/125 mg in sachets are not recommended.
Patients with kidney or liver problems

If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
If you have liver problems, you may need more frequent blood tests to monitor liver function.

How to take Amoxicillin and Clavulanic Acid ratiopharm Italia

Take with meals.
Just before taking Amoxicillin and Clavulanic Acid ratiopharm Italia, open the sachet and mix the contents with half a glass of water.
Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
Do not take Amoxicillin and Clavulanic Acid ratiopharm Italia for longer than 2 weeks. If you still do not feel better, you should return to your doctor.

If you take more Amoxicillin and Clavulanic Acid ratiopharm Italia than you should
If you take too much Amoxicillin and Clavulanic Acid ratiopharm Italia, symptoms may include gastrointestinal disturbances (nausea, vomiting or diarrhoea) or seizures. Talk to your doctor as soon as possible. Take the medicine package or bottle with you so you can show it to the doctor.
If you forget to take Amoxicillin and Clavulanic Acid ratiopharm Italia
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
If you stop taking Amoxicillin and Clavulanic Acid ratiopharm Italia
Continue taking Amoxicillin and Clavulanic Acid ratiopharm Italia until the treatment is complete, even if you start to feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you should pay attention to
Allergic reactions:

skin rash (appearance of red spots on the skin);
inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body;
fever, joint pain, swelling of the glands in the neck, armpits, or groin;
swelling, sometimes of the face or mouth ( angioedema ), causing difficulty breathing;
collapse (drop in blood pressure);
chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis Syndrome). Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin and Clavulanic Acid ratiopharm Italia.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually containing blood and mucus, stomach pain and/or fever.
Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
DIES has been mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine).
Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
If you experience these symptoms, contact your doctor as soon as possible for advice.
Inform your doctor if any of the following side effects occur:
Very common (may affect more than 1 in 10 people)

diarrhoea.

Common (may affect up to 1 in 10 people)

thrush ( candidiasis – a fungal infection of the vagina, mouth, or skin folds);
nausea, especially when taking high doses; if affected, take Amoxicillin and Clavulanic Acid ratiopharm Italia before meals;
vomiting.

Uncommon (may affect up to 1 in 100 people)

skin rash, itching;
raised itchy rash (urticaria);
indigestion;
dizziness;
headache.

Uncommon side effects that may be detected through blood tests:

increase in certain proteins ( enzymes ) produced by the liver.

Rare (may affect up to 1 in 1,000 people)

skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ).

If you notice any of these symptoms, contact your doctor urgently.
Rare side effects that may be detected through blood tests:

low number of cells involved in blood clotting;
low number of white blood cells.

Other side effects
Other side effects occur in a very limited number of people, but their exact frequency is not known (the frequency cannot be estimated from the available data).

allergic reactions (see above);
intestinal inflammation (see above);
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
severe skin reactions:
widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis );
widespread red rash with small pus-filled blisters ( bullous dermatitis and exfoliative dermatitis );
a red, scaly rash with raised areas under the skin and blisters ( generalized acute exanthematous pustulosis );
flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms);
skin rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease).

If you experience any of these symptoms, contact your doctor immediately.

inflammation of the liver ( hepatitis );
jaundice, caused by increased levels of bilirubin in the blood (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes;
inflammation of the kidney tubules;
blood takes longer to clot;
reversible hyperactivity;
seizures (in people taking high doses of Amoxicillin and Clavulanic Acid ratiopharm Italia or who have kidney problems);
black hairy tongue (aspergillosis: a type of fungus);
tooth staining (in children), usually removable by brushing.

Side effects that may be detected through blood or urine tests:

severe reversible decrease in white blood cells (leucopenia);
low number of red blood cells ( haemolytic anaemia );
crystals in the urine leading to acute kidney damage.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid ratiopharm italia

Store below 25 °C. Keep in the original packaging to protect the medicine from light and moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Amoxicillina e Acido Clavulanico ratiopharm Italia contains

The active substances are amoxicillin and clavulanic acid.
The other components are colloidal silica, lemon flavour, strawberry flavour, xanthan gum, sucrose.

Description of the appearance of Amoxicillina e Acido Clavulanico ratiopharm Italia and contents of the
package
Amoxicillina e Acido Clavulanico ratiopharm Italia 875 mg + 125 mg powder for oral suspension is presented
in sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V. Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
Laboratorio Reig Jofré, S.A. - C/Jarama s/n, Poligono Industrial - 45007 Toledo - Spain

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can reduce the emergence of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended only for the illness you currently have.
Please pay attention to the following advice in order to help prevent the emergence of bacterial resistance, which leads to the failure of antibiotic activity.

It is very important that you take the antibiotic at the correct dose, at the scheduled times, and for the correct number of days. Read the instructions in the package leaflet and, if anything is unclear, ask your doctor or pharmacist for clarification.
Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
Do not use antibiotics that have been prescribed for other people, even if you have an infection similar to theirs.
Do not give your antibiotics, which were specifically prescribed for you, to other people.
If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal. ---------------------------------------------------------------------------------------------------------------------------